TOTY SOLARIA MINERAL- titanium dioxide, zinc oxide cream 
Chipican LLC

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toty Solaria Mineral

Active Ingredients

Titanium Dioxide 7.0%

Zinc Oxide 6.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use On damaged or broken skin

When using this product Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if Rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

After 80 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours

Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses

Other information

Inactive Ingredients

Water, Dimethicone, Isododecane, C12-15 Alkyl Benzoate, Hydrogenated Didecene, Butyloctyl Salicylate, Aluminum Hydroxide, Styrene/Acrylates Copolymer, Phenethyl Benzoate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Nylon-12, Calaguala ( Polypodium leucotomos) Leaf Extract, Ferulic Acid, 3-O-Ethyl Ascorbic Acid, Tocopheryl Acetate, Tocopherol, Cutleaf Grouncherry (Physalis angulata) Extract, Green Tea ( Camellia sinensis) Extract, Plankton ( Chlamydomonas reinhardti) Extract, Arginine, Melanin, Caprylyl Glycol, Isohexadecane, Disteardimonium Hectorite, Hydrogen Dimethicone, Phenylpropanol, Polyhydroxystearic Acid, Magnesium Sulfate, Dimethicone/PEG-10/15 Crosspolymer, Propanediol, Triethoxycaprylylsilane, Propylene Carbonate, Caprylic/Capric Triglyceride, Panthenyl Triacetate, Butylene Glycol, Propylene Glycol, Ethyl Linoleate, Oleyl Alcohol, Pentylene Glycol, Oxothiazolidine, Dipropylene Glycol, Sodium Citrate, Palmitoyl Hydroxypropyltrimonium Amylopectin/Glycerin Crosspolymer, 1,2-Hexanediol, Lecithin, Sodium Benzoate, Hydrogenated Lecithin, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77491), Ferrosoferric Oxide (CI 77499)).

Package Label.Principal Display Panel- Sample

NDC 82141-3161-2 (toty Solaria Mineral, Sample)

toty.

SOLARIA

MINERAL

SPF 50+

ANTIOXIDANT

SUNSCREEN SERUM

SERUM ANTIOXIDANTE

PROTECTOR SOLAR

.....................................................................................

BROAD SPECTRUM SPF 50+

VERY WATER RESISTANT

(80 MINUTES)

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA

(80 MINUTOS)

0.17 oz/5g

Toty Solaria Mineral (Sample)

Package Label.Principal Display Panel

NDC 82141-3161-1 (toty Solaria Mineral)

toty.

SOLARIA

MINERAL

SPF 50+

ANTIOXIDANT

SUNSCREEN SERUM

SERUM ANTIOXIDANTE

PROTECTOR SOLAR

.....................................................................................

BROAD SPECTRUM SPF 50+

VERY WATER RESISTANT (80 MINUTES)

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

1.69 fl. oz/50 mL

Toty Solaria Mineral

Package Label. Princip[al Display Panel- Travel Size)

NDC 82141-3161-3 (toty Solaria Mineral, Travel Size)

toty.

SOLARIA

MINERAL

SPF 50+

ANTIOXIDANT

SUNSCREEN SERUM

SERUM ANTIOXIDANTE

PROTECTOR SOLAR

.....................................................................................

BROAD SPECTRUM SPF 50+

VERY WATER RESISTANT (80 MINUTES)

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

1.0 fl. oz/30 mL

toty Solaria Mineral Travel Size

TOTY SOLARIA MINERAL 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82141-3161
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
OXOTHIAZOLIDINE (UNII: M6U1ZG59XD)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
NYLON-12 (UNII: 446U8J075B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
3-PHENYL-1-PROPANOL (UNII: U04IC2765C)  
HYDROGENATED DIDECENE (UNII: 048B98MT5O)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
PROPANEDIOL (UNII: 5965N8W85T)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
ARGININE (UNII: 94ZLA3W45F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERULIC ACID (UNII: AVM951ZWST)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
CHLAMYDOMONAS REINHARDTII (UNII: QS58JP94CS)  
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER (UNII: 7F9WLW26M2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82141-3161-11 in 1 CARTON06/01/202301/31/2024
150 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:82141-3161-21 in 1 CARTON06/01/2023
25 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:82141-3161-31 in 1 CARTON01/08/2024
330 g in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:82141-3161-41 in 1 CARTON06/01/2023
450 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/01/2023
Labeler - Chipican LLC (118132015)
Establishment
NameAddressID/FEIBusiness Operations
Industrial Farmaceutica Cantabria SA470471158manufacture(82141-3161) , label(82141-3161) , pack(82141-3161)

Revised: 2/2024
Document Id: 1052c87e-42c3-60a2-e063-6394a90a970d
Set id: e9d590d8-e71a-0715-e053-2a95a90a5acf
Version: 3
Effective Time: 20240201
 
Chipican LLC